AZD3293 Thorough QT Study in Healthy Male Volunteers



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:5/3/2014
Start Date:January 2014
End Date:April 2014
Contact:Robert Alexander, MD
Email:ClinicalTrialTransparency@astrazeneca.com
Phone:267495 9149

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A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Subjects

A thorough QT study of AZD3293

A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to
Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared
to Placebo, Using Open-Label AVELOX (moxifloxacin) as a Positive Control, in Healthy Male
Subjects

Inclusion Criteria:

1. Provision of signed, written and dated informed consent prior to any study-specific
procedures

2. Healthy male subjects must be able to understand and be willing to comply with study
procedures, restrictions and requirements

3. Healthy male subjects aged 18 to 55 years

4. Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30

5. Clinically normal findings on physical examination in relation to age, as judged by
the investigator.

Exclusion Criteria:

1. History of any clinically significant disease or disorder which may either put the
subject at risk because of participation in the study, or influence the results or
the subject's ability to participate in the study

2. History or presence of gastrointestinal, hepatic or renal disease or any other
condition known to interfere with absorption, distribution, metabolism or excretion
of drugs

3. History of previous or ongoing psychiatric disease/condition including psychosis,
affective disorder, anxiety disorder, borderline state and personality disorder

4. History of neurologic disease, including seizures (with the exception of febrile
infantile seizures), recent memory impairment or clinically significant head injury

5. History of psychotic disorder among first degree relatives
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